Randomised controlled trial comparing anal fistula closure rates between anal fistula plug insertion and ligation of intersphincteric fistula tract in patients with complex anal fistula of cryptoglandular origi
Recruiting
- Conditions
- Complex anal fistulaSurgery - Surgical techniquesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12611001167954
- Lead Sponsor
- Concord Repatriation General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Patients with complex transphincteric anal fistula of cryptoglandular origin determined by examination under anaesthesia and endoanal ultrasography will be eligible for the study following the insertion of a seton into the fistula tract for a minimum of 6 weeks.
Exclusion Criteria
1) Active anorectal or perianal sepsis
2) Anovaginal or rectovaginal fistulas
3) Ileo-anal pouch vaginal fistulas
4) Allergy or intolerance to porcine products
5) Ulcerative colitis or Crohn’s disease
6) Previous anal fistula plug, LIFT procedure, fistulotomy, lateral anal sphincterotomy and anal sphincter repair
7) Pregnancy at recruitment or parturition during study follow-up period
8) Patients deemed unable to give informed consent on clinical grounds
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fistula healing rate will be assessed clinically in outpatient setting from the absence of symptoms of pain & discharge from the fistula tract or surgical wounds. Endoanal ultrasonography or MRI will not be performed as granulation tissue is present in both healing and recurring fistulas and thus have similar appearances on both imaging modalities.[6, 12, 26 and 52 weeks after intervention]
- Secondary Outcome Measures
Name Time Method Continence as assessed using the Cleveland Clinic Florida Fecal Incontinence Score[6, 12, 26 and 52 weeks after intervention]